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FDA Inspectional Approach, Paul Bellamy (733 KB)

FDA Inspectional Approach, Paul Bellamy (733 KB)

FDA Inspectional Approach, Paul Bellamy (733 KB)

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SOP CONCERNS<br />

• SOPS ARE NOT SPECIFIC. For example,<br />

SOPS read like they were downloaded off<br />

the internet or purchased from a<br />

consultant. Language used in the SOPS is<br />

vague and not enough detail is provided in<br />

SOP so that reader could accurately or<br />

consistently perform the said task.<br />

12

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